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USFDA APPLICATION NUMBER - 21928 / DOSAGE - TABLET;ORAL - EQ 1MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| varenicline tartrate(UNII: 82269ASB48) (varenicline - UNII:W6HS99O8ZO) | varenicline | 0.5mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | AvKARE | Cardinal Health | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | Ascend Laboratories, LLC |
|---|---|---|---|---|---|---|
| anhydrous dibasic calcium phosphate(L11K75P92J) | ||||||
| cellulose, microcrystalline(OP1R32D61U) | ||||||
| croscarmellose sodium(M28OL1HH48) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
| magnesium stearate(70097M6I30) | ||||||
| MALTODEXTRIN(7CVR7L4A2D) | ||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| silicon dioxide(ETJ7Z6XBU4) | ||||||
| STEARIC ACID(4ELV7Z65AP) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||
| TRIACETIN(XHX3C3X673) |
